Inappropriate IP administration (dose/timing dispensing error

Inappropriate IP administration (dose/timing dispensing error
Type of indicator Risk
Risk Category IMP
Golden KRI NO
Therapeutic Area General
IF Risk-Event the study drug is not dispesed properly
DUE TO Risk Causes misunderstanding of the dispensing instructions or any other reason
THEN Risk Impact MAY RESULT Subject safety or the drug efficacy negative impact
Risk Indicator Inappropriate IP administration (dose/timing dispensing error
Metric Percent of Study drug underdosing/study drug overdosing in IMP dispensations
Unit %
What level should be measured Study,Country,Site,Subject
Purpose Identify instances where there are deviations in IP administration that may compromise Subject safety or impact the integrity of clinical trial data.
Description KRI measures the percentage of instances (sites) where investigational products are administered incorrectly in terms of dosage or timing.
Formula Devide a number of instances of inappropriate IP administration due to dose or timing errors by a total number of IP administrations and multiply by 100%.
Suggested Thresholds - High >15 %
Suggested Thresholds - Medium >10 %
Associated Metric 1 Number of instances of inappropriate IP administration due to dose or timing errors
Associated Metric 2 Number of IP administrations
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